Chiropractic and Exercise for Seniors With Low Back Pain

NCT00269321 | Completed Phase 2

• 1 other identifier: 5R18HP01424
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this randomized clincal trial is to assess the relative effectiveness of three conservative treatment approaches for seniors with chronic low back pain: 1) chiropractic manual treatment plus home exercise, 2) supervised exercise plus home exercise and 3) home exercise alone.

Conditions

Low Back Pain

Keywords

Randomized; Clinical Trial; Low Back Pain; Chiropractic; Manual Therapies; Exercise

Outcome Measures

Primary Outcomes (1)

• Patient-rated pain (0-11 box scale)

  short term = 12 weeks; long term = 52 weeks

Secondary Outcomes (6)

• General Health

  short term = 12 weeks; long term = 52 weeks

• Disability

  short term = 12 weeks; long term = 52 weeks

• Improvement

  short term = 12 weeks; long term = 52 weeks

• Satisfaction

  short term = 12 weeks; long term = 52 weeks

• Medication use

  short term = 12 weeks; long term = 52 weeks

Study Arms (3)

1

EXPERIMENTAL

Procedure: Chiropractic Manual treatment + home exercise (procedure+behavior)

2

EXPERIMENTAL

Procedure: Supervised rehabilitative exercise+home exercise

3

ACTIVE COMPARATOR

Behavioral: Home exercise

Interventions

Chiropractic Manual treatment + home exercise (procedure+behavior) PROCEDURE

The number of treatments will be determined by the individual chiropractor. Chiropractic manual treatment will be limited to gentle spinal manipulation, mobilization and flexion-distraction therapy with light soft tissue massage as indicated to facilitate the manual therapy. Patients will attend 4, 45-minute small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about low back pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active.

1

Supervised rehabilitative exercise+home exercise PROCEDURE

The rehabilitative exercise program will consist of 20, 1-hour sessions. It is a modification of exercise protocols used in previous studies by the investigators and incorporates recommendations of leading rehabilitative exercise specialists. Patients will attend 4, 45-minute small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about low back pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active.

2

Home exercise BEHAVIORAL

Patients will attend 4, 45-minute small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about low back pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active.

3

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Sub-Acute and chronic low back pain (Defined as current episode more than 6 weeks duration.)
• Quebec Task Force classifications 1, 2, 3 and 4. (This includes patients with back pain, stiffness or tenderness, with or without musculoskeletal signs and neurological signs.{1570})
• years of age and older
• Independent ambulation
• Community dwelling (residency outside nursing home)
• Score of 20 or more on Folstein Mini-Mental State Examination{13246}
• Stable prescription medication plan (no changes in prescription medications that affect musculoskeletal pain in previous month)

You may not qualify if:

• Referred low back pain from local joint lesions of the lower extremities or from visceral diseases
• Significant infectious disease Determined by history or by referral to supplementary diagnostic tests
• Ongoing treatment for low back pain by other health care providers
• Mean baseline low back pain score of 20 percentage points or less
• Contraindications to exercise Determined by history or by referral to supplementary diagnostic tests (i.e., uncontrolled arrhythmias, third degree heart block, recent ECG changes, unstable angina, acute myocardial infarction, acute congestive heart failure, cardiomyopathy, valvular heart disease, poorly controlled blood pressure, uncontrolled metabolic disease
• Contraindications to spinal manipulation (i.e. Progressive neurological deficits blood clotting disorders; infectious and non-infectious inflammatory or destructive tissue changes of the spine; severe osteoporosis)

Sponsors & Collaborators

• Northwestern Health Sciences University: lead
• Health Resources and Services Administration (HRSA): collaborator
• Berman Center for Outcomes and Clinical Research: collaborator

Study Sites (1)

Wolfe-Harris Center for Clinical Studies, Northwestern Health Sciences University

Bloomington, Minnesota, 55438, United States

Location

Related Publications (2)

• Schulz C, Evans R, Maiers M, Schulz K, Leininger B, Bronfort G. Spinal manipulative therapy and exercise for older adults with chronic low back pain: a randomized clinical trial. Chiropr Man Therap. 2019 May 15;27:21. doi: 10.1186/s12998-019-0243-1. eCollection 2019.

  PMID: 31114673 DERIVED

• Maiers MJ, Hartvigsen J, Schulz C, Schulz K, Evans RL, Bronfort G. Chiropractic and exercise for seniors with low back pain or neck pain: the design of two randomized clinical trials. BMC Musculoskelet Disord. 2007 Sep 18;8:94. doi: 10.1186/1471-2474-8-94.

  PMID: 17877825 DERIVED

Related Links

• Click here for a description of the Wolfe-Harris for Center for Clinical Studies

MeSH Terms

Conditions

Low Back Pain; Motor Activity

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Gert Bronfort, PhD

  Northwestern Health Sciences University

  PRINCIPAL INVESTIGATOR

• Roni Evans, MS

  Northwestern Health Sciences University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 21, 2005
• First Posted: December 23, 2005
• Study Start: October 1, 2003
• Study Completion: March 1, 2008
• Last Updated: June 28, 2013

Record last verified: 2013-06

Locations

US (1)